← Back to catalogue

Phoenix Diagnostics

FDA UDI

Class II (US FDA UDI)

by Phoenix Diagnostics, Inc.

Identity

Trade Name
Phoenix Diagnostics FDA UDI
Generic Name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator FDA UDI
Device Name
Buffer Pack 348 for Siemens / Bayer Blood Gas Systems FDA UDI
Model / Reference
3-223 FDA UDI
Description
Buffer Pack 348 for Siemens / Bayer Blood Gas Systems FDA UDI

Identifiers

Catalog Number
3-223 FDA UDI
Primary DI / UDI-DI
00852676007056 FDA UDI
510(k) Number
K902267 FDA UDI
FDA Product Code
JIX FDA UDI
GMDN Term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 460 Milliliter FDA UDI

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Phoenix Diagnostics by Phoenix Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator.

Cleared under the same submission

K902267 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Phoenix Diagnostics, Inc.

Sources (1)

  • FDA UDI 3ed34938-cb90-40a7-ad33-6bb625689fbf 38 fields · synced May 30, 2026